Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice

<p>Abstract</p> <p>Background</p> <p>Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study.</p> <p>Methods</p> <p>The study is designed as a pragmatic randomised clinical trial (RCT) with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP) with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema). Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100) or a group receiving podiatric treatment (n = 100). Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale) and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index). Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using multilevel level analysis.</p> <p>Discussion</p> <p>Strength of this study is the comparison between two common primary care treatments for forefoot problems, ensuring a high external validity of this trial.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2212">NTR2212</a></p

Short-term effects of an educational program on health-seeking behavior for infections in patients with type 2 diabetes:a randomized controlled intervention trial in primary care

OBJECTIVE: The aim of this study was to assess the short-term effects of an educational program on (determinants of) self-reported health-seeking behavior for infections of the urinary tract (UTIs) and lower respiratory tract (LRTIs) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a randomized controlled trial, 1,124 patients with type 2 diabetes aged between 44 and 85 years participated. The intervention consisted of a multifaceted educational program with an interactive meeting, a leaflet, a Web site, and a consultation with the diabetes care provider. The program focused on the needs of patients, apparent from a prior focus group and questionnaire study. The primary outcome measure was an indicator of health-seeking behavior for UTIs and LRTIs, defined as the proportion of participants with a positive score on at least seven of nine determinants, six from the Health Belief Model and the additional three domains of knowledge, need for information, and intention. The primary outcome was measured with questionnaires at baseline and after 5 months. RESULTS: Complete outcome data were available for 468 intervention group patients and 472 control group patients. In all, 68% of the intervention group patients attended the meeting. At baseline, 28% of the participants from the intervention group had a positive score on seven of the nine determinants, compared with 27% from the control group. After the educational program, these percentages were 53 and 32%, respectively (P < 0.001). CONCLUSIONS: Our educational program positively influenced determinants of health-seeking behavior for common infections in patients with type 2 diabetes

Three years follow-up of screen-detected diabetic and non-diabetic subjects: who is better off? The ADDITION Netherlands study

Abstract Background People with non-diabetic hyperglycaemia might be at risk of lacking adequate control for cardiovascular risk factors. Our aim was to determine the extent of health care utilization and provision in primary care and to evaluate the risk of cardiovascular disease in persons with an elevated risk score in a stepwise diabetes screening programme. Methods A total of 56,978 non-diabetic patients, aged 50–70 years, from 79 practices in the Netherlands were invited to participate in a screening programme starting with a questionnaire. Those with an elevated score, underwent further glucose testing. Screened participants with type 2 diabetes (n = 64), impaired glucose tolerance (IGT) (n = 62), impaired fasting glucose (IFG) (n = 86), and normal glucose tolerance (NGT) (n = 142) were compared after three years regarding use of medication, care provider encounters and occurrence of CVD. Results In all glucose regulation categories cardiovascular medication was prescribed more frequently during follow-up with the strongest increase in diabetic patients. Number of practice visits was higher in diabetic patients compared to those in the other categories. Glucose, lipids, and blood pressure were measured most frequently in diabetic patients. Numbers of cardiovascular events in participants with NGT, IFG, IGT and diabetes were 16.7, 32.6, 17.3 and 15.7 per 1,000 person-years (non significant), respectively. Conclusion After three years of follow-up, screened non-diabetic participants with an elevated risk score had cardiovascular event rates comparable with diabetic patients. Screened non-diabetic persons are at risk of lacking optimal control for cardiovascular risk factors while screen-detected diabetic patients were controlled adequately.</p

Prediction of complicated urinary tract infections in patients with type 2 diabetes:a questionnaire study in primary care

BACKGROUND: Relatively few data are available to predict a complicated course of community-acquired complicated urinary tract infections (UTIs) in patients with diabetes type 2 (DM2). The aim of this study was to assess predictors for a complicated course of UTIs in DM2 patients in primary care. METHOD: We conducted a cross-sectional questionnaire study among DM2 patients aged over 45 years as part of an educational trial. The combined outcome measure was a complicated course of UTI, defined as a self-reported episode of acute pyelonephritis, prostatitis or recurrent cystitis in the 12 months before the trial. Patients with an outcome were all verified by review of medical records. A prediction model was derived with multivariable logistic regression analysis. RESULTS: Of the 1151 trial participants, 94 (8%) had a self-reported community-acquired complicated course of UTIs and 62 (66%) of these were medically-attended. Independent predictors for a complicated course were age above 60 years (adjusted odds ratio (OR): 1.74; 95% confidence interval (CI): 0.99-3.03), chronic use of antibiotics (adjusted OR: 5.50; 95% CI: 2.31-13.08), more than 6 physician contacts in previous year (adjusted OR: 3.60; 95% CI: 2.00-6.49), hospitalization in previous year (adjusted OR: 1.36; 95% CI: 1.00-1.85), renal disease (adjusted OR: 4.92; 95% CI: 1.59-15.18) and incontinence of urine (adjusted OR: 3.78; 95% CI: 1.93-7.38). Area under the receiver-operating curve was 0.72 (95% CI: 0.66-0.78). Analysis according to medically attended complicated UTIs did not change our findings. CONCLUSION: Easily obtainable predictors from medical history can be used to accurately predict a complicated course of UTIs in DM2 patients